SPG Pulsed Radiofrequency for Chronic Cluster Headache

Официальное название

The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache

Обзор

Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.

Вмешательства

• Процедура PRF
  After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the PRF group received PRF treatment in automatic mode for 360 s, at a maximum of 42°C, pulse frequency of 2 Hz, and pulse width of 20 ms.
• Процедура NB
  After the puncture needle reached the sphenopalatine ganglion (SPG), patients in the NB group received nerve block with a mixture of 40 mg of triamcinolone and 2 ml of 0.75% bupivacaine with 2 ml of normal saline and 1:100000 epinephrine.

Первичные конечные точки

• The mean attack frequency in the last 4 weeks (week 8-12) after procedure [Срок оценки: In the last 4 weeks (week 8-12) after procedure]

Вторичные конечные точки (7)

• Mean attack frequency [Срок оценки: From baseline to each 4-week interval through 1 year after procedure]
• 50% reduction of mean attack frequency [Срок оценки: From baseline to each 4-week interval through 1 year after procedure]
• 30% reduction of mean attack frequency [Срок оценки: From baseline to each 4-week interval through 1 year after procedure]
• Patient Global Impression of Improvement [Срок оценки: At month 1, month 2, month 3, month 6, and month 12 after procedure]
• Mean attack intensity [Срок оценки: From baseline to each 4-week interval through 1 year after procedure]
• Patient satisfaction scores [Срок оценки: At month 1, month 2, month 3, month 6, and month 12 after procedure]
• The incidence of perioperative adverse events [Срок оценки: Across 1 year after procedure]

Критерии участия

Критерии включения

• Chronic cluster headache;
• At least four attacks per week;
• Minimum age of 18 years;
• Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.

Критерии исключения

• Pregnancy or breastfeeding;
• Presence of cardiac pacemaker or other neuromodulatory devices;
• Pyschiatric and cognitive disorders;
• Serious drug habituation or overuse of acute-headache medication;
• History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
• Infection at the puncture site;
• Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fang Luo — Пекин

Публикации

• Goadsby PJ, Sahai-Srivastava S, Kezirian EJ, Calhoun AH, Matthews DC, McAllister PJ, Costantino PD, Friedman DI, Zuniga JR, Mechtler LL, Popat SR, Rezai AR, Dodick DW. Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial. Lancet Neurol. 2019 Dec;18(12):1081-1090. doi: 10.1016/S1474-4422(19)30322-9. PMID 31701891
• Schoenen J, Snoer AH, Brandt RB, Fronczek R, Wei DY, Chung CS, Diener HC, Dodick DW, Fontaine D, Goadsby PJ, Matharu MS, May A, McGinley JS, Tepper SJ, Jensen RH, Ferrari MD; IHS Standing Committee for Clinical Trials; IHS cluster headache trial guideline subcommittee. Guidelines of the International Headache Society for Controlled Clinical Trials in Cluster Headache. Cephalalgia. 2022 Dec;42(14): PMID 36268950
• Wilbrink LA, de Coo IF, Doesborg PGG, Mulleners WM, Teernstra OPM, Bartels EC, Burger K, Wille F, van Dongen RTM, Kurt E, Spincemaille GH, Haan J, van Zwet EW, Huygen FJPM, Ferrari MD; ICON study group. Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose- PMID 34146510

Идентификаторы

NCT: NCT06787677 · KY 2018-027-02-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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